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A Prospective UK Multicentre Study of Kidney Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01769924
Recruitment Status : Unknown
Verified January 2013 by Jonathan N. Townend, University Hospital Birmingham NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : January 17, 2013
Last Update Posted : January 17, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
Studies of patients with established kidney disease, even when this is mild, appear to show that they are at high risk of heart failure, stroke and sudden cardiac death. This may be because kidney disease causes stiffening of the arteries in the body which means that the heart and brain are damaged by high blood pressure. By studying patients before and after the removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for the first time in man the effect of an isolated reduction in kidney function on the structure and function of the cardiovascular system.

Condition or disease Intervention/treatment
Living Kidney Donors Other: Nephrectomy

Study Design

Study Type : Observational
Estimated Enrollment : 880 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of A Reduction in Glomerular Filtration Rate After Nephrectomy on Arterial Stiffness (EARNEST)
Study Start Date : February 2013
Estimated Primary Completion Date : February 2015
Groups and Cohorts

Group/Cohort Intervention/treatment
Live kidney donors
Other: Nephrectomy
Healthy controls

Outcome Measures

Primary Outcome Measures :
  1. Aortic Pulse Wave Velocity (aPWV) adjusted for mean arterial pressure and heart rate [ Time Frame: 12 months ]
  2. 24 hour ambulatory systolic blood pressure [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Clinic blood pressure [ Time Frame: 12 months ]
  2. Number of patients newly diagnosed with hypertension [ Time Frame: 12 months ]
    As defined by commencement of antihypertensive therapy

  3. Augmentation index (AIx) [ Time Frame: 12 months ]
  4. Central blood pressure [ Time Frame: 12 months ]
    Central haemodynamics

  5. N-terminal prohormone of brain natriuretic peptide (NT-proBNP) [ Time Frame: 12 months ]
  6. Urinary albumin: creatinine ratio (ACR) [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
Urine, serum and plasma.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample

Inclusion Criteria:

  • A donor group will be recruited from all patients undergoing donor nephrectomy.
  • A contemporaneous control group will be recruited from clinics, advertisements within and outside the institutions and from any local volunteer databases.

Exclusion Criteria:

  • These will be the same for donors and controls. The current nationally set exclusion criteria for donors include age/glomerular filtration rate (GFR) cutoff, diabetes mellitus, any history of cardiovascular or pulmonary disease, evidence of hypertensive end-organ damage, known left ventricular dysfunction (including ejection fraction < 40%) and atrial fibrillation.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769924

Contact: Jonathan N Townend john.townend@uhb.nhs.uk
Contact: William E Moody william.moody@nhs.net

Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
British Heart Foundation
University Hospital Birmingham NHS Foundation Trust
North Bristol NHS Trust
University Hospitals Coventry and Warwickshire NHS Trust
Kings Health Partners
Glasgow Western Infirmary
Belfast Health and Social Care Trust
Sheffield Teaching Hospitals NHS Foundation Trust
Study Chair: John Cockcroft, PhD Cardiff
Study Director: Ian B Wilkinson Cambridge Heart Inc.
Principal Investigator: Jonathan N Townend Birmingham
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonathan N. Townend, Consultant Cardiologist and Honorary Reader in Cardiology, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01769924     History of Changes
Other Study ID Numbers: A092761
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

Keywords provided by Jonathan N. Townend, University Hospital Birmingham NHS Foundation Trust:
kidney donors
arterial stiffness
blood pressure